JUNIOR ASSOCIATE

Company Overview

Role Purpose

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

Implement and maintain appropriate quality systems, in alignment with regulatory requirements, to ensure appropriate quality oversight, monitor QMS performance and effectiveness, and drive continual improvement

Implement quality systems

Ensure all time compliance with regulatory requirements.

Ensure inspection readiness, face audits and inspections, propose and implement corrective and preventive action plans, and respond to queries and inspection observations.

Plan and budget adequate and appropriate resources

Interact closely with business and cross functional teams to ensure timely business deliverables

Actively participate in quality review meetings and initiatives, lead crossfunctional initiatives, and support quality team members as needed

Other quality related responsibilities in relation to implementation and maintenance of quality system processes

Manage the team, in alignment with BBL strategy vision, to ensure appropriate and adequate personnel are available to

i. Implement quality systems and monitor QMS performance and effectiveness

ii. Prepare and review procedures required for quality assurance activities

iii. Review procedures, protocols, reports, data, etc.

iv. Control, retain, and archive quality system documents and records

v. Review, assess, and approve deviations and control nonconformities.

vi. Review and verify corrective and preventive actions

vii. Review and evaluate change proposals, and approve changes

viii. Perform, report, and followup internal audits

ix. Manage vendor quality. Ensure appropriate agreements. Perform and report audits of vendors, CROs, contract testing labs, etc.

x. Train quality and functional personnel

xi. Perform validations and review validation documentation